The Effect of a Developed Device for Mother With Flat or Inverted Nipples

NCT06978543 | Completed DMC

• 1 other identifier: TNKU-Z.BALKAN-3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Breast milk alone can meet all the elements necessary of babies during the first 6 months. However, some problems prevent breast milk from being taken, including concern about milk insufficiency, hyperlactation, clogged milk ducts, engorgement, mastitis, painful, injured/cracked nipples, flat or inverted nipples. As there is insufficient nipple projection in mothers with flat or inverted nipples, it has been reported that babies have difficulty latching on to the breast and have problems breastfeeding. Also, it has been found that mothers with nipples shorter than 7 mm need more support. Many interventions are recommended to solve flat or inverted nipple problems. In our study, a device developed for flat or inverted nipples was used by researchers. Thisa device developed for flat or inverted nipples was developed by researchers based on their experience and literature. This study was designed to evaluate the effects of the device developed for flat or inverted nipples for mother just already giving birth on nipple length, baby's attachment to the breast and breastfeeding duration, "LATCH Breastfeeding Assessment Tool" scores and and the duration of exclusive breastfeeding time in the first 6 months. The hypotheses of the study are as follows: (H1): Nipple length of mothers in the intervention gorup is longer. (H2): Babies in the intervention gorup would have a shorter attachment time on the breast. (H3): Babies in the intervention group have a longer duration of one breastfeeding. (H4): The LATCH breastfeeding diagnosis and evaluation score of the intervention group is higher. (H5): Babies in the intervention gorup have a longer exclusive breastfeeding time.

Conditions

Inverted Nipple; Exclusive Breastfeeding

Keywords

Flat nipple; Inverted nipple; LATCH Score; Exclusive breastfeeding; Injector method

Outcome Measures

Primary Outcomes (5)

• The mean nipple lengths of the mothers

  Immediately after the interventions on the mother's nipples, the nipple length was measured by the nurse.

  Through study completion, an average of 1 year

• The LATCH score

  Immediately after the interventions on the mother's nipples, the LATCH score was measured by the nurse. LATCH Breastfeeding Diagnosis and Assessment Scale form : The LATCH scale is a diagnostic tool developed based on the Apgar score assessment model. Each criterion of the LATCH Breastfeeding Diagnosis and Assessment Scale is scored 0, 1, 2. Breastfeeding success is assessed by adding up the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. Increasing scores from the scale indicate breastfeeding success.

  Through study completion, an average of 1 year

• The duration of baby's attachment to the breast

  Immediately after the interventions on the mother's nipples, the duration of baby's attachment to the breast was measured by the nurse.

  Through study completion, an average of 1 year

• The duration of baby's one time breastfeeding

  Immediately after the interventions on the The duration of baby's one time breastfeeding was measured by the nurse.

  Through study completion, an average of 1 year

• Feeding Taypes of Babies

  Mothers and babies in both groups were contacted by the same nurse after discharge and asked whether the babies had been exclusively breastfed.

  Through study completion, an average of 1 year.

Study Arms (2)

DFIN Group

EXPERIMENTAL

The intervention group: A device developed for flat or inverted nipples (DFIN) was used. This device was developed by researchers. The developed device was printed on a 3D printer and applied to mothers. The way of using the tool is written in detail in the method.

Device: A Prototype Device Developed for Flat or Inverted Nipples (DFIN)

Injector Group

ACTIVE COMPARATOR

The syringe method used routinely in the unit was applied by the researcher to mothers immediately after delivery.

Device: Modified injector

Interventions

A Prototype Device Developed for Flat or Inverted Nipples (DFIN) DEVICE

This is a non-commercial, researchers-developed prototype breastfeeding aid (DFIN) designed for mothers with flat or inverted nipples. Produced using 3D printing, the device is made of biocompatible material and is not commercially registered. Prior to its application in patients, official approval for use was obtained from the Turkish Medicines and Medical Devices Agency (TITCK). DFIN was developed based on clinical experience and literature. Previous studies showed that warming the breast increases nipple temperature and enhances milk production. DFIN contains a 150-200 mL reservoir of warm water (39-41°C) to apply heat directly. It is anatomically designed to fit the breast and is kept in place for 10 minutes. Then the piston in the DFIN is pulled, with the mother's maximum comfort.

DFIN Group

Modified injector DEVICE

The syringe method used routinely in the unit was applied by the researcher to mothers immediately after delivery. In this method, the thin part to which the needle is attached is cut with a sharp knife, the plunger is placed in this area and the syringe is applied to the flat or inverted nipple to create a vacuum

Injector Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The mothers:
• were aged 18 years or older,
• had normal or cesarean delivery at term,
• had a history of uncomplicated pregnancy or birth,
• had a nipple length of 7 mm or less.

You may not qualify if:

• The mothers:
• Mothers with preterm and multiple births,
• babies with congenital anomalies,
• women and babies with any health problems were excluded from the study.

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, Suleymanpasa, 59030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Serap BALCI, PhD,Prof.

  ISTANBUL UNİVERSİTY CERRAHPAŞA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Applications were made by the researcher (The intervention group:The device developed for mothers with flat or inverted nipples and the control group:injector method). Measurements (the diameter and length of the women's nipples, Baby's one time breastfeeding duration, Baby's one time attachment to the breast duration, LATCH scores, Babies exclusive breastfeeding duration in six months) were made by the nurse. The data were analysed by an independent statistician other than the researchers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Principal Investigator

Model Details: The device developed for mothers with flat or inverted nipples who had just given birth, was compared with a control (injector method) group.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 18, 2025
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: May 15, 2022
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)